Efficacy and Tolerability of Nolotil i.v. vs. Placebo i.v. in the Prevention of Postoperative Pain in Children Undergoing Minor Surgery

Randomized, Double Blind, Comparative Trial of the Efficacy and Tolerability of Nolotil i.v. vs. Placebo i.v. in the Prevention of Postoperative Pain in Children of 6 and 11 Years Old Undergoing Minor Surgery

Study to assess the analgesic efficacy in the prevention of postoperative pain in children undergoing minor surgery (herniorraphy, tonsillectomy) and to assess the tolerability of Metamizol in this group of patients.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Placebo; Drug: Magnesium metamizol

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children of either sex between 6 and 11 years of age
• Patients undergoing routine inguinal hernia repair or tonsillectomy
• Written informed consents by the guardian, according to the guidelines of Good Clinical Practice and current legislation
• The ability of the patient to understand and carry out the visual analogue scale assessments
• Patients with a physical status American Society of Anesthesiologist I or II class

Exclusion Criteria:

• The use of any drug with analgesic properties in the 24 hours prior to the administration of the study drug
• Surgery with a foreseen duration over 60 minutes
• Patients with a nutritional index of less than 90 or greater than 120
• Patients with a body mass index which was not between the 3rd centile and the 97th centile for age
• Patients with any illness or malformation (except hernia) which, in the doctor's opinion, contraindicated the use of metamizol (aplastic anemia, agranulocytosis of a toxicological etiology, severe renal disease, etc.)
• Patients who have received in the previous 7 days or need currently anticoagulant treatment
• Significant allergy or known hypersensitivity to metamizol, its excipients and/or to other nonsteroidal antiinflammatory drugs
• Patients in whom the anesthetic regimen required by the protocol cannot be used
• Patients who have participated in another clinical trial in the past four weeks or are currently participating in another clinical trial
• Patients with any psychological disturbance which, in the investigator's opinion makes the patient unsuitable for inclusion in the trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo
Experimental: Magnesium metamizol	Drug: Magnesium metamizol; Other Names: Nolotil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of children requiring rescue medication	up to 4 hours after drug administration

Secondary Outcome Measures

Outcome Measure	Time Frame
Time from drug administration, end of surgery and first patient's awake to the administration of rescue medication	up to 4 hours
Percentage of children who require rescue medication	up to 2 hours after drug administration
Evaluation of the pain intensity by the patient by means of a Visual Analogue Scale (VAS)	up to 4 hours
Evaluation of the pain intensity by the patient by means of a four points Verbal Rating Scale (VRS)	up to 4 hours
Assessment of the state of the patient by the guardian by means of the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) test	up to 4 hours
Assessment of the partial efficacy by the investigator by means of a four points VRS	up to 4 hours
Assessment of the total efficacy by the investigator by means of a four points VRS	after 4 hours
Number of patients with adverse events (AE)	up to 4 hours
Number of withdrawals due to AEs	up to 4 hours
Assessment of the total tolerability of the assigned treatment by the investigator by means of a four points VRS	after 4 hours

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: March 1, 2002
• Primary Completion (Actual): March 1, 2004

Study Registration Dates

• First Submitted: July 8, 2014
• First Submitted That Met QC Criteria: July 8, 2014
• First Posted (Estimate): July 9, 2014

Study Record Updates

• Last Update Posted (Estimate): July 10, 2014
• Last Update Submitted That Met QC Criteria: July 9, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antipyretics; Dipyrone
• Other Study ID Numbers: 1093.18